Special Drug Use Investigation for AMERGE Tablet (Long-term)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01332383
First received: April 7, 2011
Last updated: June 30, 2014
Last verified: June 2014

April 7, 2011
June 30, 2014
May 2009
October 2013   (final data collection date for primary outcome measure)
The number of adverse drug reactions and serious adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01332383 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Special Drug Use Investigation for AMERGE Tablet (Long-term)
Special Drug Use Investigation for AMERGE Tablet (Long-term)

To investigate the long-term safety and efficacy of AMERGE (naratriptan hydrochloride) on Japanese patients with migraine headache in clinical setting

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with migraine headache who are naive to AMERGE

Migraine Disorders
Drug: Naratriptan
Patients prescribed AMERGE
Patients with migraine disorders prescribed AMERGE during study period
Intervention: Drug: Naratriptan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must use AMERGE for the first time

Exclusion Criteria:

  • Patients with hypersensitivity to naratriptan or any of the components.
  • Patients with history, symptoms, or signs of myocardial infarction, ischemic cardiac or angina inversa
  • Patients with history of cerebral vascular disturbance or transient ischaemic attack
  • Patients with peripheral vascular syndromes
  • Patients with uncontrolled hypertension
  • Patients with severe renal or hepatic impairment
  • Patients using treatment with another 5-HT1 agonist, an ergotamine-containing or ergot-type medication
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01332383
112925
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP